Drug factory · FDA FEI 3004010371
Cardinal Health 414, LLC
7920 Elmbrook Drive, Ste 112, Dallas, TX, United States
No problems found at FDA's last inspection, Apr 16, 2026.
No Action Indicated: inspectors found no objectionable conditions.
4 drug inspections on record since 2012: 3 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Flurpiridaz F-18 | Makes it | GE Healthcare Inc. | 0407-8787 |
| Flutemetamol F-18 | Makes it | Medi-Physics Inc. dba GE Healthcare. | 17156-067 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Apr 16, 2026 | No problems found | Drug Quality Assurance | — |
| Jul 20, 2016 | No problems found | Drug Quality Assurance | — |
| Aug 22, 2013 | No problems found | Drug Quality Assurance | — |
| Nov 30, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: manufacture; positron emission tomography drug production.